Tempo Welcome Kit MS9841001AM

GUDID 30300020948551

Convenience Kit for patients with diabetes. Contains Tempo Smart Button, lancets, testing strips, and BD needles.

ELI LILLY AND COMPANY

Glucose monitoring system IVD, home-use

• Primary Device ID: 30300020948551
• NIH Device Record Key: 401c04bf-c3ce-439a-a946-0248a8a1b357
• Commercial Distribution Discontinuation: 2026-04-17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempo Welcome Kit
• Version Model Number: MS9841
• Catalog Number: MS9841001AM
• Company DUNS: 006421325
• Company Name: ELI LILLY AND COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-545-5983
• Email: xxx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xxx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xxx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xxx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xxx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xxx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00300020948550 [Primary]
GS1	30300020948551 [Package]; Contains: 00300020948550; Package: Carton [1 Units]; Discontinued: 2026-04-17; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212217

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-03-18
• Device Publish Date: 2022-11-01

Devices Manufactured by ELI LILLY AND COMPANY

• 00300020911554 - Tempo Smart Button: 2026-03-18 Reusable connected data transfer module.
• 30300020948551 - Tempo Welcome Kit: 2026-03-18Convenience Kit for patients with diabetes. Contains Tempo Smart Button, lancets, testing strips, and BD needles.
• 30300020948551 - Tempo Welcome Kit: 2026-03-18 Convenience Kit for patients with diabetes. Contains Tempo Smart Button, lancets, testing strips, and BD needles.
• 00300021451554 - Lilly Together: 2025-04-25 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021458553 - Lilly Together: 2025-04-25 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021285555 - Lilly Together: 2024-12-04 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021286552 - Lilly Together: 2024-12-04 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021283551 - Lilly Together: 2024-08-05 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021284558 - Lilly Together: 2024-08-05 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support